FDA's Continuing Investigation Implicates Additional
Lots of Counterfeit Lipitor

The Food and Drug Administration (FDA) today announced that its continuing investigation of counterfeit Lipitor has turned up additional counterfeit quantities of the cholesterol-lowering pharmaceutical product. Two additional lots of 10 mg tablets in 90-tablet bottles, coded 20842V and 16092V, and one lot of 20 mg tablets in 90-tablet bottles, coded D270481, are involved. The labeling on each of these bottles states, “Repackaged by: MED-PRO, INC., Lexington, NE 68850.”

Since learning of problems with this product late last month, FDA investigators have aggressively pursued a variety of leads all along the supply and distribution chain. Evidence of the new lots of implicated Lipitor arose in the context of FDA’s investigation.

FDA’s advice to healthcare providers and consumers remains the same as when the agency issued its original alert on counterfeit Lipitor May 23, 2003. They should check the packaging very carefully before using Lipitor. Patients who have any of the product (labeled as “Repackaged by: MED-PRO, INC. Lexington, NE 68850”) with any of the following lot numbers should not take it, and they should return the product to their pharmacies:

• 20722V – 90-tablet bottles, 10 mg., Expiration 09-2004
• 04132V – 90-tablet bottles, 10 mg., Expiration 01-2004
• 16942V – 90-tablet bottles, 10 mg., Expiration 09-2004
• 20842V – 90-tablet bottles, 10 mg., Expiration 09-2004
• 16092V – 90-tablet bottles, 10 mg., Expiration 07-2004
• D270481 – 90 tablet bottles, 20 mg.,Expiration not available.

FDA is working closely with the individual states and with health professionals, especially with pharmacists and pharmacy associations, to alert them to this counterfeit product. Many patients taking Lipitor do not receive it in the 90-tablet bottles being recalled, but in smaller quantities from their pharmacists. Patients who are not sure whether they have the implicated product should check with their pharmacist.

FDA is also working closely with the manufacturer of Lipitor, Pfizer, Inc., on this counterfeiting problem. FDA supports the activities of legitimate manufacturers to inform the public about counterfeit products and how to identify them. Last month, FDA entered into an agreement with a major pharmaceutical trade association to cooperate more closely on cases of suspected counterfeit products.

FDA’s investigation into this matter is continuing.

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